EP2185233B1 - Anti-restenosis drug covered and eluting balloons for valvuloplasty of aortic valve stenosis for the prevention of restenosis - Google Patents

Anti-restenosis drug covered and eluting balloons for valvuloplasty of aortic valve stenosis for the prevention of restenosis Download PDF

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Publication number
EP2185233B1
EP2185233B1 EP08737275.1A EP08737275A EP2185233B1 EP 2185233 B1 EP2185233 B1 EP 2185233B1 EP 08737275 A EP08737275 A EP 08737275A EP 2185233 B1 EP2185233 B1 EP 2185233B1
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EP
European Patent Office
Prior art keywords
balloon
restenosis
drug
valvuloplasty
aortic valve
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP08737275.1A
Other languages
German (de)
English (en)
French (fr)
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EP2185233A1 (en
Inventor
Konstantinos Spargias
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Eurocor Tech GmbH
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Eurocor Tech GmbH
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Publication date
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/08—Materials for coatings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1027—Making of balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1072—Balloon catheters with special features or adapted for special applications having balloons with two or more compartments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1088—Balloon catheters with special features or adapted for special applications having special surface characteristics depending on material properties or added substances, e.g. for reducing friction

Definitions

  • BAV balloon aortic valvuloplasty
  • BAV has been well demonstrated to moderately increase aortic valve area by an average of 0.3-0.4 cm 2 and reduce mean valvular gradient by roughly 50%. This is achieved despite the use of balloon diameters of 18-24mm, not far smaller from the diameter of the aortic valve ring. Transient valve leaflet and annular stretch undoubtedly contribute to early recoil. The large majority of patients experience immediate symptomatic improvement.
  • calcific aortic stenosis is a complex cellular process with features of atherosclerosis and biomineralization similar to osteogenesis, which should have specific pathways for targeted inhibition.
  • regulated processes may play a role in restenosis following BAV. Although the mechanisms of restenosis are poorly understood, scar formation and heterotopic ossification are believed to play a central role. If specific targeted inhibition of these processes is completely or even partially successful the long-term results of the BAV procedure will improve and it may become an acceptable treatment of aortic valve stenosis in the elderly.
  • the first effort to prevent restenosis following BAV was with radiation.
  • the results of the RADAR pilot trial were published in Cathet Cardiovasc Intervent 2006;68:183-92 . This was a series of 20 patients over 80 years of age with an estimated operative mortality risk above 15%. They underwent prophylactic external beam radiation therapy (EBRT) starting the day following the BAV procedure and for 3 days.
  • EBRT prophylactic external beam radiation therapy
  • a total dose of 1200 cGy and 1500-1800 cGy was administered in the low and high dose groups of patients. Restenosis was defined as over 50% late loss of acute gain in aortic valve area.
  • the restenosis rate in the low dose group was 30% and in the high dose group 11%, results impressively better than historical controls.
  • WO2005/007219 A discloses a balloon for use in valvuloplasty of aortic stenosis according to the preamble of claim 1.
  • Paclitaxel for example is known to inhibit fibroblast migration in vitro and in vivo, and can be the first one to be used for coating a BAV balloon.
  • inhibitors of mineralization/calcification such as MGP, fetuin, osteopontinad and others or oral administration of inhibitors such as phosphate binding drugs (used by all chronic renal failure patients) and NSAA (i.e. the selective cyclooxygenase-2 (COX-2) inhibitor Rofecoxib).
  • phosphate binding drugs used by all chronic renal failure patients
  • NSAA i.e. the selective cyclooxygenase-2 (COX-2) inhibitor Rofecoxib
  • An effective drug-coated balloon for BAV would prevent restenosis with local drug delivery at the aortic valve leaflets at the time of balloon inflation. This method is obviously superior to EBRT, which requires prolonged hospital stay and considerable material and human resources.
  • DIOR (Eurocor, Germany) is a balloon catheter coated with paclitaxel (3 mcg/mm 2 of balloon surface area) for use in the coronary arteries. It releases 35% of the drug with every 20-second contact with the vessel wall (i.e. 2 such dilatations release almost 70% of the loaded drug). It has been shown to significantly reduce late lumen loss and coronary in-stent restenosis compared with an uncoated balloon.
  • the aortic valvuloplasty balloon first introduced in the late 70s and today there are plenty plain valvuloplasty balloons manufacturers for use in heart valves.
  • the present invention provides a balloon for use in valvuloplasty of aortic stenosis according to claim 1, and in particular concerns an aortic valvuloplasty balloon that is covered by and elutes an antirestenosis substance (drug) to the aortic valve tissues upon contact with them during its inflation. The drug is released to the aortic valve tissues and exerts its antirestenotic action.
  • DIOR a balloon catheter
  • any other drug-covering technology mechanical or chemical bonding of the drug to the balloon surface
  • the time of the balloon inflation in BAV cannot exceed 10-15 seconds, but multiple balloon inflations can be applied to reach a total time of balloon-valve contact of almost 1 minute. This allows the almost complete release of the loaded drug to the contacted tissue.
  • the quantity of the drug administered at the valve tissues by the balloon may be increased by storing higher dose of the drug at the balloon surface with appropriate technology (i.e. more and/or deeper and/or larger micropores).
  • a pilot trial in animals is designed to prove the concept of local drug delivery at the aortic leaflets followed by studies with experimental models of animal aortic valve stenosis and ultimately studies in humans with aortic valve stenosis.
  • This balloon will achieve contact and drug release at the inferior/external surfaces of the aortic valve, which have considerably larger area compared to the superior/internal surface for geometrical reasons.
  • the balloon is hour-glass shaped with the drug loaded only in the middle slimmer part (waist) of the balloon. With such a design the drug will be administered in a targeted manner at the aortic valve tissue only, and contact with other structures will be avoided. In addition, such a shape will act protectively with regards to any premature release of the drug into the blood flow.
  • the balloon when inflated may form a circular crease at its middle part, the surface of which is covered by the drug ( Figure 4 ).
  • the pathological aortic valve contacts this balloon at the level of its drug-covered crease.
  • Claim 2 describes a balloon similar to the above, the only difference being that instead of forming a crease it forms a circular concave perimeter ( Figure 5 ).
  • antirestenotic and anticalcification drugs can be tested for local delivery with a coated balloon.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Child & Adolescent Psychology (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)
EP08737275.1A 2007-04-13 2008-04-14 Anti-restenosis drug covered and eluting balloons for valvuloplasty of aortic valve stenosis for the prevention of restenosis Active EP2185233B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GR20070100224A GR20070100224A (el) 2007-04-13 2007-04-13 Μπαλονι βαλβιδοπλαστικης για την στενωση αορτικησβαλβιδας που φερει επιστρωση εκλυομενης φαρμακευτικης ουσιας η οποια επιδρα προληπτικα κατα της επαναστενωσης.
PCT/GR2008/000024 WO2008125890A1 (en) 2007-04-13 2008-04-14 Anti-restenosis drug covered and eluting balloons for valvuloplasty of aortic valve stenosis for the prevention of restenosis

Publications (2)

Publication Number Publication Date
EP2185233A1 EP2185233A1 (en) 2010-05-19
EP2185233B1 true EP2185233B1 (en) 2020-04-01

Family

ID=39481218

Family Applications (1)

Application Number Title Priority Date Filing Date
EP08737275.1A Active EP2185233B1 (en) 2007-04-13 2008-04-14 Anti-restenosis drug covered and eluting balloons for valvuloplasty of aortic valve stenosis for the prevention of restenosis

Country Status (4)

Country Link
US (1) US20110098737A1 (el)
EP (1) EP2185233B1 (el)
GR (1) GR20070100224A (el)
WO (1) WO2008125890A1 (el)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BRPI0806727B8 (pt) 2007-01-21 2021-06-22 Hemoteq Ag método para o revestimento de um cateter de balão
GR20070100291A (el) * 2007-05-14 2008-12-19 Κωνστατινος Σπαργιας Μπαλονια βαλβιδοπλαστικης για την στενωση αορτικης βαλβιδας που φερουν επιστρωση εκλυομενης φαρμακευτικης ουσιας η οποια επιδρα προληπτικα κατα της επαναστενωσης
US9192697B2 (en) 2007-07-03 2015-11-24 Hemoteq Ag Balloon catheter for treating stenosis of body passages and for preventing threatening restenosis
ES2550634T3 (es) 2009-07-10 2015-11-11 Boston Scientific Scimed, Inc. Uso de nanocristales para un balón de suministro de fármaco
JP5933434B2 (ja) 2009-07-17 2016-06-08 ボストン サイエンティフィック サイムド，インコーポレイテッドＢｏｓｔｏｎ Ｓｃｉｅｎｔｉｆｉｃ Ｓｃｉｍｅｄ，Ｉｎｃ． 薬剤送達バルーンの製造方法
US8889211B2 (en) 2010-09-02 2014-11-18 Boston Scientific Scimed, Inc. Coating process for drug delivery balloons using heat-induced rewrap memory
US8669360B2 (en) 2011-08-05 2014-03-11 Boston Scientific Scimed, Inc. Methods of converting amorphous drug substance into crystalline form
US9056152B2 (en) 2011-08-25 2015-06-16 Boston Scientific Scimed, Inc. Medical device with crystalline drug coating
CN105435356A (zh) * 2014-09-28 2016-03-30 徐州亚太科技有限公司 一种二尖瓣球囊扩张导管

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US5304121A (en) * 1990-12-28 1994-04-19 Boston Scientific Corporation Drug delivery system making use of a hydrogel polymer coating
US5674192A (en) * 1990-12-28 1997-10-07 Boston Scientific Corporation Drug delivery
US5120322A (en) * 1990-06-13 1992-06-09 Lathrotec, Inc. Method and apparatus for treatment of fibrotic lesions
US5545209A (en) * 1993-09-30 1996-08-13 Texas Petrodet, Inc. Controlled deployment of a medical device
US5620457A (en) * 1994-11-23 1997-04-15 Medinol Ltd. Catheter balloon
US6306166B1 (en) * 1997-08-13 2001-10-23 Scimed Life Systems, Inc. Loading and release of water-insoluble drugs
AU1922799A (en) * 1997-12-19 1999-07-12 Cordis Corporation Catheter system having fullerenes and method
US6364856B1 (en) * 1998-04-14 2002-04-02 Boston Scientific Corporation Medical device with sponge coating for controlled drug release
US20050137621A1 (en) * 2002-04-08 2005-06-23 Acrostak Corporation PTCA and/or PTA balloon
US7744620B2 (en) * 2003-07-18 2010-06-29 Intervalve, Inc. Valvuloplasty catheter
GR20070100291A (el) * 2007-05-14 2008-12-19 Κωνστατινος Σπαργιας Μπαλονια βαλβιδοπλαστικης για την στενωση αορτικης βαλβιδας που φερουν επιστρωση εκλυομενης φαρμακευτικης ουσιας η οποια επιδρα προληπτικα κατα της επαναστενωσης

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Also Published As

Publication number Publication date
GR20070100224A (el) 2008-11-14
EP2185233A1 (en) 2010-05-19
US20110098737A1 (en) 2011-04-28
WO2008125890A1 (en) 2008-10-23

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